G/TBT/GEN/263  
 
14 May 2019  
(19-3365) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
CLASSIFICATION OF CO BALT  
COMMUNICATION FROM T HE RUSSIAN FEDERATIO N 
The following communication , dated 8 May 2019 , is being circulated at the request of the delegation 
of the Russian Federation . 
 
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1  INTRODUCTION  
1.1.  In the document G/TBT/N/EU/629 the European Union notified the draft amendments to 
Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification , 
labelling and packaging of substan ces and mixtures and corrigendum to the Commission Regulation 
(EU) No. 2018/669.  
1.2.  The proposed amendments by the European Union include , inter alia , classification of cobalt as 
a carcinogen category 1B for all routes of exposure under the CLP regulation , and as a reprotoxic 
category 1B. The proposal could disrupt trade in a wide variety of products containing even small 
amounts of cobalt such as stainless steel. Given that stainless steel is the largest end -use of nickel , 
the proposal could also affect trade  in nickel and nickel goods , such as nickel concentrates or mattes.  
1.3.  Since the proposed measure would have negative impact on stable and traditional trade flows , 
it is of paramount importance to take into consideration all available and reliable data scien tifically 
justified and based on the full range of studies. However , the draft measure is not elaborated on the 
basis of and does not take into consideration science.  
2  CARCINOGENICITY  
2.1.  The carcinogenicity classification for the inhalation route of exposure i s based on the results 
from a two -year carcinogenicity study in mice and rats by inhalation. At the same time , the human 
studies of thousands of the most highly exposed cobalt workers have not shown any elevated cancer 
risks. However , there are no data , animal or human , to indicate that the oral route is of concern.  
2.2.  The best international practice of classification of chemicals stipulates for classification 
decisions based on risk rather than hazard. Indeed , the very introduction of REACH , and particularly  
the new use and exposure data that result from the registration obligations , set the foundation for 
risk-based regulation and classification.  
2.3.  The precautionary principle can only be invoked once a scientific assessment has been made 
as stipulated by the Communication from the Commission on the precautionary principle (see 
COM(2000) 1 , section 6.1 , p. 16) which states that "the implementation of an approach based on 
the precautionary principle should start with a scientific evaluation , as complete as possi ble, and 
where possible , identifying at each stage the degree of scientific uncertainty".  
2.4.  The legal principle, outlined by the Commission itself, has not been followed in this particular 
case, since the lack of systemic tumors  in human workers' data and in patients with cobalt -containing 
alloy implants was not considered.  G/TBT/GEN/263  
 
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  2.5.  Moreover, it is our understanding that an oral carcinogenicity study for cobalt is being prepared 
by the cobalt industry to be conducted in 2020. The study will provide hard data for any further 
classification decision with regards to carcinogenicity of the cobalt salts and cobalt metal by all routes 
of exposure.  
2.6.  We were pleased that the European Commission realized that the current methodology to 
assess the potency of cobalt metal had problems and needed to be reassessed, and in the meantime, 
a generic concentration limit would be applied. Indeed, a database of oral carcinogenicity studies 
with organic substances is not appropriate to judge potency of inorgan ic substances by inhalation 
exposure.  
2.7.  We are deeply concerned that the Commission decides to rush with the classification proposal 
for all routes of exposure in the absence of solid positive systemic carcinogenicity animal data1 while 
in the presence of t housands of data points in humans where an absence of cancer is noted. The 
only case where such a course of action would be justifiable is the case when there are reasonable 
grounds to suspect serious and immediate threat to public health, which is not the  case here. There 
are no grounds for foregoing an imminent scientific research that will provide hard data for sound 
regulatory decisions and push for a pre -emptive classification without data.  
3  REPRODUCTIVE TOXICIT Y 
3.1.  The classification of cobalt as a reprot oxic category 1B is also considered to be precautionary 
and based on speculation rather than solid evidence. In this case, there are no definitive one -
generation, two generation, or extended one generation studies with cobalt metal that demonstrate 
reprodu ctive effects or support this classification. Furthermore, even if the classification for cobalt 
metal was based on read across from cobalt salts, we understand that definitive studies do not even 
exist for the cobalt salts.  
4  COBALT CLASSIFICATIO N 
4.1.  ECHA is considering an approach to refine the classification of alloys based on relative metal 
bioavailability information. In vitro bioelution tests for the relevant routes of exposure can provide 
information on the concentration of the bioaccessible metal in the  alloy as a surrogate for the 
bioavailable metal concentration. This approach should be pursued and considered where the release 
of cobalt can be affected by the existence of a matrix compared to pure cobalt metal.  
5  IMPACT ASSESSMENT  
5.1.  Stainless steel could b e considered as unsafe for use because of this classification proposal , in 
particular in food processing , water distribution , buildings and public places , and in dental and 
medical applications. For a number of these applications , alternatives may actually  pose a much 
higher risk to consumers and the population at large , because they may not be easily cleaned and 
sterilized as stainless steel. Henceforth , this classification proposal may actually put in jeopardy the 
lives of many people rather than safeguar ding their health , and put in question the use of material 
that has been proven safe for decades.  
5.2.  Furthermore , there could be considerable international trade impact as the demand for nickel 
and nickel -containing products , such as stainless steel , could p lummet because of this proposal.  
6  CONCLUSION  
6.1.  It is clear that the measure is disproportionate with potentially far reaching consequences. It 
is not based on legal grounds nor respect the Commission's own communication on the precautionary 
                                                
1 Pheochromocytomas and pancreatic cancers observed in some animals after inhalation exposure to 
cobalt metal are considered by EU as evidence of systemic carcinogenicity. Pheochromocytomas are a common 
finding in many inhalation studies with particulates an d are considered to be secondary to lung toxicity and 
hypoxia. Even if cobalt itself mimics hypoxia, the lung effects are likely to drive the induction of 
pheochromocytomas. Pancreatic tumours are rare and therefore it is very important to have solid data on 
historical background levels; these data were lacking for cobalt metal since the US NTP had just started to use 
strain F344 NTac in their studies; in addition there was no dose -response for pancreatic tumours. Together 
both these tumour types are not so lid evidence of systemic carcinogenicity of cobalt.  G/TBT/GEN/263  
 
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  principle. Furthe rmore , the measure could also be considered as discriminatorily protectionist leading 
to trade flow distortion , unfair competition and closing of the market for safe and reputable products 
without any sound scientific grounds or justifications.  
6.2.  Therefore , we believe that an impact assessment of the proposed classification is to be 
conducted. The draft classification is to be postponed until the full range of economic , health and 
safety consequences is assessed and understood.  
6.3.  We also believe that the Commi ssion should delay the inclusion of cobalt as a carcinogen 
category 1B for all routes of exposure and a reprotoxic category 1B in the CLP until the necessary 
testing is completed. Especially as epidemiological studies show that there is no imminent threat to 
human health , and taking into account that the reprotoxicity classification is based on no definitive 
evidence.  
6.4.  We note , that this proposal is also supposed to be inconsistent with an approach within the 
legal framework of the EU since in according to t he decision of the Judgement of the General Court 
of 7 march 2019 "Kingdom of Sweden vs European Commission ", the Commission is obliged to verify 
the completeness , coherence and pertinence when it adopts scientific or technical advice of an ECHA 
Committee.  As there are clear gaps , the Commission should have addressed questions back to the 
Committee to remedy this.  
6.5.  Finally , we question the lack of consideration to the procedure of the WTO notification , as the 
Commission initially scheduled a vote on the Regu lation only 4 days after the WTO commenting 
period closed. It is our understanding that many comments have been received , and it seems that 
the European Commission has gone ahead without meaningful consideration of WTO members' 
comments.  
6.6.  It seems that the measure may be considered as inconsistent with the Article 2.2 of the 
Agreement on TBT because it's more trade restrictive than necessary , Article 2.4 because the 
methodology is not based on international practices and recommendations and Article 2.9.2 bec ause 
the period for adaptation was not provided.  
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